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ReFOCUS2: Reducing Frailty for Older Cancer Survivors Using Supplements II

Sponsor
University of Rochester (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06068543
Collaborator
(none)
118
Enrollment
1
Location
2
Arms
84
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a two-arm placebo controlled randomized clinical trial, to assess the effect of a 12-week EGCG intervention on physical frailty compared to placebo in pre-frail older cancer survivors.

Condition or Disease Intervention/Treatment Phase
  • Drug: Epigallocatechin-3-Gallate (EGCG)
  • Drug: Microcrystalline cellulose (MCC)
  • Dietary Supplement: Ascorbic Acid (Vitamin C)
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients in the intervention Arm will receive 800 mg Epigallocatechin-3-Gallate (EGCG) + 250mg Ascorbic AcidPatients in the intervention Arm will receive 800 mg Epigallocatechin-3-Gallate (EGCG) + 250mg Ascorbic Acid
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Supportive Care
Official Title:
A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jan 1, 2030
Anticipated Study Completion Date :
Dec 31, 2030

Arms and Interventions

Arm Intervention/Treatment
Experimental: Epigallocatechin-3-Gallate (EGCG)

800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily

Drug: Epigallocatechin-3-Gallate (EGCG)
800mg Epigallocatechin-3-Gallate (EGCG)
Other Names:
  • EGCG

    • Dietary Supplement: Ascorbic Acid (Vitamin C)
    250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks
    Other Names:
  • Vitamin C

    		•
    Placebo Comparator: Microcrystalline cellulose (MCC)

    800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily

    Drug: Microcrystalline cellulose (MCC)
    800mg microcrystalline cellulose (MCC)
    Other Names:
  • MCC

    • Dietary Supplement: Ascorbic Acid (Vitamin C)
    250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks
    Other Names:
  • Vitamin C

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of physical frailty measured using the Short Physical Performance Battery (SPPB) in patients in the EGCG arm compared to placebo; change in SPPB scores from baseline to 12 weeks. [12 Weeks]

      We will assess the change in SPPB scores from baseline to 12 weeks after baseline in patients in the EGCG intervention arm compared to the placebo arm.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Be age 65 or over.

    2. Be diagnosed with stage I-III Cancer

    3. Have completed curative intent treatment ≤10 years prior to screening (Patients on endocrine therapies are allowed to enroll)

    4. Have a Fried's Frailty Score (FFS) of ≥ 2

    5. Able to provide informed consent, or have consent given by patient-designated health care proxy per institutional policies and University of Rochester Cancer Control URCC guidelines.

    Exclusion Criteria:

    1. Have chemotherapy planned for the duration of the study.

    2. Have abnormal liver function tests (Alanine transaminase (ALT), Aspartate transaminase (AST), and bilirubin ≥ 3 times institutional upper limit of normal) per most recent available lab test (within 3 months of screening).

    3. Have uncontrolled or unmanaged liver disease.

    4. Consume more than 6 cups of green tea per day.

    5. Have known allergies to caffeine.

    6. Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.

    7. Be diagnosed with dementia.

    8. Cannot provide informed consent due to lack of decision-making capacity (as determined by the patient's oncologist) and has no patient-designated health care proxy per institutional policies and University of Rochester Cancer Control University of Rochester Cancer Control (URCC) guidelines.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Rochester Rochester New York United States 14627

    Sponsors and Collaborators

    • University of Rochester

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nikesha Gilmore, Assistant Professor, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT06068543
    Other Study ID Numbers:
    • UOCPC23048
    First Posted:
    Oct 5, 2023
    Last Update Posted:
    Oct 5, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Inflammation
    Frailty
    Vitamins
    Ascorbic Acid
    Epigallocatechin gallate

    Study Results

    No Results Posted as of Oct 5, 2023